Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

Hepatocellular Carcinoma Clinical Trial

Official title:

Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04780789
• Other study ID #: 01-080616/EK
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives:

To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.

Description:

The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically

• at least one TACE undergone at the University Hospital Brno

• initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)

• follow-up on or before December 31, 2019.

Exclusion Criteria:

• when the inclusion criteria are not met.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Hepatocellular Carcinoma by BCLC Stage

Intervention

Procedure:
• Transarterial Chemoembolization
A contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk Memorial Cancer Institute, Masaryk University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive factors for overall survival and progression-free survival	RECIST, mRECIST, volumetric analysis	4 years 11 months
Primary	Interobserver variability of the methods used for assessing tumor response to the treatment	RECIST, mRECIST, volumetric analysis	4 years 11 months
Secondary	Time from observation until death due to any cause (or censoring)	Overall survival	4 years 11 months
Secondary	Time from observation until disease progression or death	Progression-free survival	4 years 11 months
Secondary	Response to the treatment, as assessed by RECIST (v.1.1)	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis	4 years 11 months
Secondary	Response to the treatment, as assessed by mRECIST	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis	4 years 11 months
Secondary	Response to the treatment, as assessed by volumetric analysis	Objective Tumour Response will be assessed by the investigators on CT/MRI image	4 years 11 months